The New Jersey Board of Medical Examiners announced Tuesday it disciplined three surgeons who participated in clinical trials of a medical device without disclosing payments tied to the results of the study.
The board reprimanded Drs. Richard A. Balderston, Thomas J. Errico and Jeffrey A. Goldstein, all of whom signed consent orders and did not admit or deny the allegations.
Goldstein and Errico were involved in clinical studies of the ProDisc spinal disc replacement device at the NYU Medical Center and Hospital for Joint Disease. Balderston was the clinical investigator of the device at the University of Pennsylvania’s Pennsylvania Hospital, according to the state board.
When physicians renew their New Jersey licenses, they have to disclose any financial payments in excess of $10,000 received from medical device manufacturers, according to the state board. Goldstein and Errico answered “no” to that question, and Balderston’s lack of disclosure to Pennsylvania Hospital violated certain New Jersey statutes, according to the consent order.
The board assessed $60,000 in civil penalties and $17,500 in cost reimbursements against Errico. Goldstein was assessed $30,000 in civil penalties and $10,000 in cost reimbursements. All three physicians must provide proof of successfully completing a board-approved ethics course.
Goldstein issued the following statement to NJBIZ: “For the benefit of patients, I fully agree and support the need for disclosure with regard to physician and industry relationships and I proactively disclose my relationships to all of my surgical patients. Over the past 10 years, since the inception of the ProDisc study, the rules about disclosure have been rapidly changing and improving and making the process more transparent. My investment and consulting relationships with regard to the ProDisc study have been fully disclosed to both NYU and to the NJ Board of Medical Examiners and any inconsistencies were not intentional. In the interest of time, while admitting no wrongdoing, it was agreed to enter into a consent order.”
Balderston’s attorney was not available for comment. Errico’s attorney, SNR Denton partner John L. Cleary II, in the Short Hills section of Millburn, had no comment.
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